An OTC will be located;
- In rural/peripheral areas where the availability of medicines/ pharmacy is problem.
- Not at the distance of less than 300m in all direction from the nearest existing OTC.
- Not in or closed to an area where there is any open sewage system, damping site or industries producing/using toxic chemicals.
B: PREMISES BUILDING,
The premises should be well built permanently with;
- Solid walls, painted white and easily cleaned.
- Solid floor which is easy to clean (tiles)
- Leak proof Roof, ceiling board /gypsum.
- Double front doors; strong security outer door & inner glass door.
- No access to any other room which not part of the OTC.
- Temperature control facility fan/air conditioner
- internal area of not less than 8*8 feet, and not more than 9*8 feet
- internal height of not less than 8 feet and not more than 10 feet
There should be clear demarcation of;
- Dispensing area
- Customer area
NOTE; The partition consist of glass counter, display case and a movable section of counter that should be arranged in such a way that they prevent any unauthorized entrance to the dispensing area.
- Shelves shall be made of smooth surface durable wood/aluminium.
- Shelves shall contain Not less than 3 rows, the lowest row to be not less than 2ft from the floor and the upper most row to be not less than 2ft from the roof.
Dispensing shall be under an authorized dispenser who can be any medical practitioner in contract with OTC owner (pharm tech. nursing assistance, etc.)
E: RECORD KEEPING
Records to be kept shall include
- Patient drug register
To be always near for reference;
- A List of authorized medicine for OTC by ZFDA
- The premises shall be located away from sites or activities that emit obnoxious materials like fumes and contaminants, offensive trade (bars) etc.
- Premises located within or near petrol station shall be furnished in such a way that the surrounding activities including fuel does not affect in anyway the quality of medicines and dispensation process.
- The premises shall be required to address among other issues, the fire prevention facilities.
- Premises located within shopping centers, e.g. Supermarkets, restaurants etc., shall be confined and restricted from other activities conducted thereat.
- The premises shall be designed such that, it shall have no direct link to a building with a bar, restaurant, medical laboratories, dispensary, clinics or in direct link to residential houses where the business is housed.
- The premises shall have clear address indicated in the application form for easy communication and reach during supervision and inspection.
- The premises shall have a sign board conspicuously displayed and the pharmacy identification logo displayed at the main entrance.
B: PREMISES DESIGN
- The premises shall be durable, safe and made of permanent building materials so as to protect pharmaceuticals from potential harmful influences.
- The premises shall be roofed with corrugated sheets, concrete slabs or tiles and shall have the floor minimally made up of cement, terrazzo, tiles or any other hard washable surfaces.
- The premises shall be designed and equipped so as to provide protection against rodents, birds, vermin etc.
- The rooms shall be painted with white or cream washable paint with smooth washable finishing.
- The surrounding should be maintained so as to minimize dust, soil and other contamination to enter the building.
- The premise shall have sufficient lighting (note colored or dim light) and an adequate ventilating AC. The premise will have a sink for hygienic purposes and the premise will always be maintained in a clean state
- The premise shall have a refrigerator for storing medicines which need to be stored below 25 degrees centigrade (SHALL BE MONITORED BY A THERMOMETER KEPT IN THE REFRIGIRATOR AND TEMPERATURE SHALL BE RECORDED IN LOG SHEETS)
- Premises to be constructed in such a way that medicines or cosmetics on shelves or cupboards are protected from direct sunrays. (PREMISE TEMPERATURE SHALL BE MONITORED BY A THERMOMETER FIXED IN THE PREMISE AND TEMPERATURE SHALL BE RECORDED IN LOG SHEETS)
- The premise shall equip FIRE EXTINGUISHER in case of fire emergency
- Premises should be sufficiently secured to prevent theft and Unauthorized entry and a “NO SMOKING “sign should be conspicuously displayed at the entrance.
C: Premises layout (Retail Pharmacy)
- Area of 20sq meters (Retail Pharmacy)
- Ceiling concrete slab
- Height 5 meters
- Store 2.5sq meters
D: Premises layout (Whole sale pharmacy)
The wholesale pharmacy premises shall have a minimum total area of at least 40sq meter and rooms shall not have less than 2.5m internal height and a store with an area not less than 5 sq meters.
E: Storage conditions
- A Pharmacy, whether Retail or Wholesale, shall have a store for storing medicines not displayed on the shelves on cupboards
- The floor of the store shall be concrete and ease to clean.
- The premise, including the store shall be free from infestation by vermin, rodents, insects and pets.
- The premise including the store shall have adequate shelving.
- The store shall have enough pallets to accommodate all the medicines in the store